Back to resultsPenicillin Allergy in Shfayim Clinic
Primary Purpose
Penicillin Allergy
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Amoxicillin
Sponsored by
About this trial
This is an interventional other trial for Penicillin Allergy focused on measuring Penicillin Allergy, chalenge test, primary clinic
Eligibility Criteria
Inclusion Criteria:
penicillin allergy in the medical record
Exclusion Criteria:
pregnancy lack of informed consent
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
treatment
Arm Description
penicillin chalange test, as descibed.
Outcomes
Primary Outcome Measures
immidiate urticarial reaction
shortness of breath, angioedema
Secondary Outcome Measures
rash
body rash or itch seen by patient or physician
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03499457
Brief Title
Penicillin Allergy in Shfayim Clinic
Official Title
Penicillin Allergy in Shfayim Clinic
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2018 (Anticipated)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clalit Health Services
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
revising penicillin allergy in the medical records, by taking full medical history and giving a challange test, in order to imrove the medical records and treatment possibilities.
Detailed Description
issuing a list of patients with a title of penicillin allergy in their medical record. inviting these patients to an appointmnet with their family physician, in which a specific history will be take to evaluate the quality of the allergy.
patients with suscpition of a life threatening allergic reaction will be reffered to an allergy clinic for the challange test. the rest of the pateints will be given the test in the primary clinic: 1ml (50 grams) of amoxicillin, and an hour later a full dose of 500 mg amoxicillin.
after determining no allergic reaction develops the title will be erased from the medical record.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Penicillin Allergy
Keywords
Penicillin Allergy, chalenge test, primary clinic
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment
Arm Type
Experimental
Arm Description
penicillin chalange test, as descibed.
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Intervention Description
chalange test of 50 mg, and after an hour 500 mg
Primary Outcome Measure Information:
Title
immidiate urticarial reaction
Description
shortness of breath, angioedema
Time Frame
with 2 hours of test
Secondary Outcome Measure Information:
Title
rash
Description
body rash or itch seen by patient or physician
Time Frame
with 2 hours of test
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
penicillin allergy in the medical record
Exclusion Criteria:
pregnancy lack of informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
lital f goldberg, MD. MPH.
Phone
972544248284
Email
litalmargalith@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
lital f goldberg, MD. MPH
Organizational Affiliation
Clalit Health Services
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Penicillin Allergy in Shfayim Clinic
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